QC Laboratory Associate

Overview:    TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide.   Our client is a leading biotechnology company that combines technological insight with world-class manufacturing, scientific expertise, and process excellence and helps their customers to deliver new and innovative medicines that help treat a wide range of diseases. Our client specializes in pharmaceutical ingredients, Bioscience, Biopharmaceuticals, Custom manufacturing, Biotechnology, Life science ingredients, Nutrition, Microbial Control, Agriculture, Materials Science, Personal Care, and cell and gene therapy.    Job Title:     QC Associate I / QC Laboratory AssociateLocation:     Vacaville, CA - 95688Duration:     12 Months    Job Type:    Temporary Assignment Work Type: Onsite  Summary With limited supervision, the QC Associate I is responsible for performing direct materials testing in compliance with cGMP regulations. Core duties include execution of laboratory testing, trend analysis, documentation review, discrepancy support (OOS, OOT, OOE), and general laboratory support activities. In collaboration with QC leadership, the QC Associate II contributes to achieving departmental and organizational objectives. ResponsibilitiesPerform a broad variety of basic and moderately complex tests with documentation according to GMPReview data and assess against established acceptance criteriaPerform technical review of peer-generated dataEvaluate data to identify trends and/or establish limitsIdentify discrepancies; provide input to design of quality investigations and CAPA (corrective actions preventive actions) initiatives as neededIdentify and troubleshoot technical problemsIdentify gaps in systems and proceduresReceive and provide trainingParticipate in assay transfer and assay validationPerform equipment qualification / maintenancePrepare and maintain standards, controls, stocks, cultures, etc. per established proceduresSupport the maintenance and compliance of operational areasAssure and apply GMP throughout operationsCoordinate with customers to support multi-site operational activitiesSupport internal and external audits and regulatory inspectionsWorks to meet schedules, timelines, deadlinesParticipate in and/or lead group and project teamwork; project and process improvementsWrite protocols and reports under limited supervisionMeets scheduled performance of 95% on timePerform other duties as requested by managers to support Quality activities.Required SkillsB.S./B.A. degree and 1-3 years experience or Master’s Degree plus one year experience or an equivalent combination of education and experience. Degrees are preferably in relevant scientific disciplines and experience is in the pharmaceutical or biopharmaceutical industry.Strong verbal and written communication skills, ability to organize and present information both formally and informally.Demonstrated ability to apply knowledge of scientific theories, principles, and techniques used in analytical or biological test procedures.Routinely exercises sound judgment, reasoning and problem solving.Capable of working under limited supervision and determining own short term priorities.TekWissen® Group is an equal opportunity employer supporting workforce diversity.TekWissen is an emerging global human capital, recruitment and IT services organization. Operating since 2009, we draw upon more than a decade of staffing experience to deliver critical talent acquisition solutions and IT engagements for our clients. We’re founded on a culture that is passionate about delivering tailored solutions, that create lasting partnerships.Our global footprint covers six countries: United States, Canada, Australia, India, United Kingdom and the Philippines. This allows us to work in close partnership with organizations and manage everything from global talent needs with demanding resourcing strategies, to single sites with lower recruitment volumes. TekWissen® is an equal opportunity employer supporting workplace diversity.

Salary : $20 - $25